Metagenomics for Ocular Inflammation

NCT06974162 | Recruiting

• 3 other identifiers: CHUC100425/WM/0072354543
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to apply a diagnostic test called 'metagenomic sequencing' to identify the involvement of potential infections in patients with ocular inflammation, where this hasn't been detected by currently available standard testing. For many people with ocular inflammation, no cause is ever found for their disease. In some cases, an infection or infectious trigger is suspected, but currently available tests are inadequate. Metagenomic sequencing can identify almost every globally known infection (bacteria, virus, fungi, parasites) in a sample. Therefore, it has the potential to identify an infection that has caused or triggered ocular inflammation, and as a consequence may help to identify specific treatments. It has the potential to improve our understanding of how to diagnose and treat people with this problem. This study will allow us to test the technique that has been previously optimised for brain infections, on ocular fluids. Participants will be 18 years of age or over and have active ocular inflammation which is suspected to be due to an infection, or an autoimmune process which has been triggered by an infection, but identification of this infection has not been possible using the investigations available as part of standard NHS care. Participants will be identified by the treating clinical team as requiring a sample of fluid from inside of the eye, and some of this fluid will be sent for metagenomic sequencing alongside standard testing. This study will be conducted at Moorfields Eye Hospital, London and will last for approximately a year. Participants will undergo additional non-invasive ocular imaging on the day of their clinic visit, but will not have to attend any additional research visits.

Conditions

Uveitis; Aqueous Humor; Infection

Keywords

Metagenomics; Uveitis; Aqueous Humor; Ophthalmology

Outcome Measures

Primary Outcomes (1)

• The percentage of participants who receive a clinically viable result from metagenomic sequencing

  12 months

Secondary Outcomes (1)

• The number of patients who receive a result that leads to a change in treatment and beneficial outcome from metagenomic sequencing

  12 months

Study Arms (1)

Patients with ocular inflammation presumed to be infectious or para-infectious

Patients with Ocular Inflammation undergoing Metagenomics on Aqueous Humour

Diagnostic Test: Metagenomic sequencing of aqueous humor; Diagnostic Test: Ocular Imaging

Interventions

Metagenomic sequencing of aqueous humor DIAGNOSTIC_TEST

Metagenomic Sequencing on aqueous humor surplus to diagnostic requirements

Patients with ocular inflammation presumed to be infectious or para-infectious

Ocular Imaging DIAGNOSTIC_TEST

Ocular imaging with anterior segment OCT, laser flare photometry, confocal microscopy and colour fundus photography.

Patients with ocular inflammation presumed to be infectious or para-infectious

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in the UK attending Moorfields Eye Hospital, London.

You may qualify if:

• years of age or older with the capacity to consent
• Standard of care has not determined a clinical diagnosis
• Active ocular inflammation with risk of visual loss
• Clinically suspected infectious or para-infectious cause of ocular inflammation

You may not qualify if:

• Contraindication to ocular fluid sampling
• Where an urgent result within 5 days is clinically required

Sponsors & Collaborators

• Moorfields Eye Hospital NHS Foundation Trust: lead
• Great Ormond Street Hospital for Children NHS Foundation Trust: collaborator

Study Sites (1)

Moorfields Eye Hospital NHS Foundation Trust

London, United Kingdom

RECRUITING

Related Publications (3)

• Atkinson L, Lee JC, Lennon A, Shah D, Storey N, Morfopoulou S, Harris KA, Breuer J, Brown JR. Untargeted metagenomics protocol for the diagnosis of infection from CSF and tissue from sterile sites. Heliyon. 2023 Sep 9;9(9):e19854. doi: 10.1016/j.heliyon.2023.e19854. eCollection 2023 Sep.

  PMID: 37809666 BACKGROUND

• Penner J, Hassell J, Brown JR, Mankad K, Storey N, Atkinson L, Ranganathan N, Lennon A, Lee JCD, Champsas D, Kopec A, Shah D, Venturini C, Dixon G, De S, Hatcher J, Harris K, Aquilina K, Kusters MA, Moshal K, Shingadia D, Worth AJJ, Lucchini G, Merve A, Jacques TS, Bamford A, Kaliakatsos M, Breuer J, Morfopoulou S. Translating metagenomics into clinical practice for complex paediatric neurological presentations. J Infect. 2023 Nov;87(5):451-458. doi: 10.1016/j.jinf.2023.08.002. Epub 2023 Aug 7. No abstract available.

  PMID: 37557958 BACKGROUND

• Doan T, Acharya NR, Pinsky BA, Sahoo MK, Chow ED, Banaei N, Budvytiene I, Cevallos V, Zhong L, Zhou Z, Lietman TM, DeRisi JL. Metagenomic DNA Sequencing for the Diagnosis of Intraocular Infections. Ophthalmology. 2017 Aug;124(8):1247-1248. doi: 10.1016/j.ophtha.2017.03.045. Epub 2017 May 16. No abstract available.

  PMID: 28526549 BACKGROUND

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITH DNA

Metagenomic Sequencing on aqueous humor

MeSH Terms

Conditions

Uveitis; Infections

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Central Study Contacts

Research Administration at Moorfields Eye Hospital R&D

CONTACT

+44 20 7253 2411; moorfields.crfenquiries@nhs.net

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 15, 2025
• Study Start: June 12, 2025
• Primary Completion (Estimated): June 12, 2026
• Study Completion (Estimated): July 12, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Within 12 months of study completion, for 5 years held in the Clinical Research Facility at Moorfields Eye Hospital.
• Access Criteria: On request to Moorfields Eye Hospital

Locations

GB (1)